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Umbilical Cord Mesenchymal Stem Cells Injection for Diabetes Secondary Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT02287831
Recruitment Status : Unknown
Verified February 2016 by Pingping Huang, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 11, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Pingping Huang, Institute of Hematology & Blood Diseases Hospital

Tracking Information
First Submitted Date  ICMJE November 2, 2014
First Posted Date  ICMJE November 11, 2014
Last Update Posted Date February 25, 2016
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02287831 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2014)
  • Ankle-Brachial pressure index [ Time Frame: 3 months ]
    Self-control,compared with non-treatment ABI≧0.01
  • Walking distance [ Time Frame: 3 months ]
  • Pain [ Time Frame: 3 months ]
    Rest pains on rating scales ranged from 0 points for the best (complete relief of pain with no use of analgesics) to 4 points for the worst result.Self-control,compared with non-treatment ,the score≧1.
  • Laser Doppler evaluation of blood perfusion at ischemic limb [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cells Injection for Diabetes Secondary Peripheral Arterial Disease
Official Title  ICMJE Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Diabetes Secondary Peripheral Arterial Disease
Brief Summary The purpose of this study is to assess the safety and efficacy of umbilical cord mesenchymal stem cells in diabetes with peripheral arterial disease.
Detailed Description Diabetes is a common chronic disease with significant morbidity and mortality. One devastating complication of diabetes is peripheral arterial disease (PAD), which may result in limb loss.In our study,patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2)。After 4 and 8 weeks, patients were injected the same number of cells. Follow-up index include: efficacy (pain,cold, numbness, Intermittent claudication distance, skin temperature,limb cyanosis area, area and depth of ulcers, gangrene range,ankle-brachial index, Transcutaneous partial pressure of oxygen ,lower limb amputation rate and , blood perfusion, Digital subtraction angiography) and safety (infection of the injection site, and tumour generation).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Peripheral Arterial Disease
Intervention  ICMJE Biological: umbilical cord mesenchymal stem cells
patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2). After 4 and 8 weeks, patients were injected the same number of cells.
Study Arms  ICMJE Experimental: umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Intervention: Biological: umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 6, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 18-75 years
  2. Patients confirmed diagnosed with diabetes secondary to peripheral vascular disease , ankle-brachial index < 0.9
  3. Poor distal arterial outflow tract
  4. Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
  5. Poor physical condition can not tolerate surgery
  6. Patients are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
  2. Severe or acute organ damage
  3. Presence of malignancy
  4. Pregnancy or lactating patients
  5. HIV positive
  6. ABI≧0.9
  7. A history of severe allergies related cell therapy
  8. Conservative treatment < 3 months
  9. Acute limb ischemia
  10. Local obvious infection uncontrolled
  11. Alcoholics or drug abusers within a year
  12. Severe psychiatric disorder.
  13. Patients need surgical treatment
  14. Above the ankle gangrene
  15. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02287831
Other Study ID Numbers  ICMJE 13ZCZDSY02200
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pingping Huang, Institute of Hematology & Blood Diseases Hospital
Study Sponsor  ICMJE Institute of Hematology & Blood Diseases Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pingping Huang, M.D. Institute of Hematology & Blood Diseases Hospital
PRS Account Institute of Hematology & Blood Diseases Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP